Omegaflex peri

Package leaflet: Information for the user

Omegaflex peri
Infusion emulsion
Please read all of this leaflet carefully before the medicine is administered, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

1. What Omegaflex peri is and what it is used for
2. Important information before use of Omegaflex peri
3. How to use Omegaflex peri
4. Possible side effects
5. How to store Omegaflex peri
6. Contents of the pack and other information

1. What Omegaflex peri is and what it is used for

Omegaflex peri contains fluids and substances called amino acids, electrolytes and fatty acids, which are essential for body growth or recovery. It also provides calories in the form of carbohydrates and fats.
Omegaflex peri is indicated for use in children over two years of age, adolescents and adults.
You receive Omegaflex peri when you are unable to take food normally. This may occur in many situations, for example, during recovery after surgery, injuries or burns, or when you are unable to absorb food from the stomach and intestines.

2. Important information before using Omegaflex peri

When not to use Omegaflex peri

• if the patient is allergic to any active substance, eggs, peanuts, soy, fish, or any of the ingredients of this medicine (listed in section 6);
• this medicine must not be given to newborns, infants, or young children under two years of age.

Omegaflex peri must also not be used if the patient has any of the following conditions:

• life-threatening circulatory disorders, such as those occurring during collapse or shock;
• heart attack or stroke;
• severe blood clotting disorders or risk of bleeding (severe coagulopathy, worsening hemorrhagic tendencies);
• blockage of blood vessels by blood clots or fat (thrombosis);
• severe liver failure;
• disorders of bile flow (intrahepatic cholestasis);
• severe kidney failure if not receiving kidney replacement therapy;
• disturbances in the body's electrolyte balance;
• fluid deficiency or excess water in the body;
• fluid in the lungs (pulmonary edema);
• severe heart failure;
• certain metabolic disorders, such as:
  • excess lipids (fats) in the blood,
  • inherited disorders of amino acid metabolism,
  • abnormally high blood sugar levels requiring more than 6 units of insulin per hour,
  • metabolic disturbances that may occur after surgery or trauma,
  • coma of unknown origin,
  • inadequate tissue oxygenation,
  • abnormally high levels of acidic substances in the blood.

Warnings and precautions
Before starting treatment with Omegaflex peri, discuss this with your doctor.
Tell your doctor if:

• the patient has heart, liver, or kidney disorders;
• the patient has certain metabolic disorders, such as diabetes, abnormal blood lipid levels, or disturbances in fluid and electrolyte balance or acid-base balance.

While receiving this medicine, the patient will be closely monitored for early signs of allergic reactions (such as fever, chills, rash, or shortness of breath).
To ensure the patient's body properly processes the nutrients administered, ongoing monitoring and tests will be performed, including various blood tests.
Medical professionals will also take measures to ensure the patient's fluid and electrolyte needs are met. In addition to Omegaflex peri, the patient will receive other nutrients to fully meet the body's requirements.

Children
This medicine must not be given to newborns, infants, or young children under two years of age.

Omegaflex peri and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Omegaflex peri may interact with certain other medicines. Tell your doctor if the patient is taking or receiving any of the following:

• insulin;
• heparin;
• medicines preventing unwanted blood clotting, such as warfarin or other coumarin derivatives;
• medicines that increase urine production (diuretics);
• medicines used to treat high blood pressure or heart conditions (ACE inhibitors, angiotensin II receptor antagonists);
• medicines used in organ transplantation, such as cyclosporine and tacrolimus;
• medicines used to treat inflammatory conditions (corticosteroids);
• hormonal preparations affecting fluid balance (adrenocorticotropic hormone [ACTH]).

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor before using this medicine. If the patient is pregnant, this medicine will only be administered if the doctor considers it absolutely necessary for her treatment. There are no data available on the use of Omegaflex peri in pregnant women.
Breastfeeding is not recommended for mothers receiving parenteral nutrition.

Driving and operating machinery
This medicine is usually administered to patients confined to bed in a hospital or clinic, which excludes driving and operating machinery. However, the medicine itself has no effect on the ability to drive or operate machinery.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

Omegaflex peri contains sodium
This medicine contains 0.931 mg/ml of sodium (a main component of common salt). This corresponds to 0.047% of the maximum recommended daily dietary intake of sodium for adults.
If one or more bags per day are required for prolonged periods, patients, especially those monitoring their dietary sodium intake, should consult their doctor or pharmacist.

3. How to use Omegaflex peri

This medicine is administered by intravenous infusion (drip), meaning through a thin tube directly into a vein. This medicine will be given through one of the smaller (peripheral) or larger (central) veins. The recommended duration of infusion for a single bag of parenteral nutrition emulsion is up to 24 hours at most.
The doctor will decide how much of this medicine the patient needs and how long treatment with this medicine will be required.
Use in children
This medicine must not be given to newborns, infants, or young children under 2 years of age.
The doctor will decide how much of this medicine the child needs and how long treatment with this medicine will be required.
Administration of a higher than recommended dose of Omegaflex peri
If too high a dose of this medicine is administered, the patient may develop so-called overload syndrome, and the following symptoms may occur:

• fluid overload and electrolyte disturbances;
• fluid in the lungs (pulmonary edema);
• loss of amino acids in urine and amino acid imbalance;
• vomiting, nausea;
• chills;
• increased blood glucose concentration;
• glucose in urine;
• fluid depletion;
• significantly higher blood component concentration than normal (hyperosmolality);
• disturbances or loss of consciousness due to extremely high blood sugar concentration;
• enlargement of the liver (hepatomegalia) with or without jaundice;
• enlargement of the spleen (splenomegalia);
• fat deposition in internal organs;
• abnormal liver function test results;
• reduced number of red blood cells (anemia);
• reduced number of white blood cells (leukopenia);
• reduced number of platelets (thrombocytopenia);
• increased number of immature red blood cells (reticulocytosis);
• breakdown of blood cells (hemolysis);
• bleeding or tendency to bleed;
• blood coagulation disorders (which may be observed as changes in bleeding time, clotting time, prothrombin time, etc.);
• fever;
• increased blood lipid levels;
• loss of consciousness.

If any of these symptoms occur, the infusion must be stopped immediately.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The adverse reactions listed below can be severe. If any of the following adverse reactions occur,
you must immediately inform the doctor who prescribed the medicine to the patient:
Rare (may affect up to 1 in 1,000 people):

• allergic reactions, for example skin reactions, shortness of breath, swelling of the lips, mouth and throat, breathing difficulties.

Other adverse reactions:
Common (may affect up to 1 in 10 people)

• irritation or inflammation of veins (phlebitis, thrombophlebitis)

Uncommon (may affect up to 1 in 100 people):

• nausea, vomiting, loss of appetite

Rare (may affect up to 1 in 1,000 people):

• increased tendency for blood to clot,
• bluish discoloration of the skin,
• shortness of breath,
• headache,
• hot flushes,
• skin redness (erythema),
• sweating,
• chills,
• feeling cold,
• high body temperature,
• drowsiness,
• chest, back, bone or lower back pain,
• low or high blood pressure.

Very rare (may affect up to 1 in 10,000 people):

• abnormally high levels of fat or sugar in the blood,
• high levels of acidic substances in the blood,
• excessive amounts of fats may lead to fat overload syndrome. More information is provided in section 3 "Overdose of Omegaflex peri".

Unknown frequency (cannot be estimated from available data):

• decrease in white blood cell count (leukopenia),
• decrease in platelet count (thrombocytopenia),
• bile flow disorders (cholestasis).

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet,
you should inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warsaw,
tel.: 22 49-21-301, fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Omegaflex peri

Keep this medicine out of sight and reach of children.
Do not store above 25°C.
Do not freeze. If accidental freezing occurs, discard the bag.
Store the bag in the outer protective pouch to protect from light.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of the stated month.

6. Contents of the package and other information

What Omegaflex peri contains
The active substances of the ready-to-use mixture are:

The other ingredients are: monohydrate citric acid (for pH adjustment), egg phospholipids for
injection, glycerol, sodium oleate, all-rac-α-Tocopherol, sodium hydroxide (for pH adjustment) and
water for injection.
What Omegaflex peri looks like and contents of the pack
The ready-to-use product is an infusion emulsion, i.e. an emulsion administered through a thin tube into
a vein.
Omegaflex peri is supplied in triple-chambered flexible bags containing:

• 1250 ml (500 ml amino acid solution + 250 ml fat emulsion + 500 ml glucose solution)
• 1875 ml (750 ml amino acid solution + 375 ml fat emulsion + 750 ml glucose solution)
• 2500 ml (1000 ml amino acid solution + 500 ml fat emulsion + 1000 ml glucose solution)

Figure A Figure B
Figure A: The multi-chamber bag is packed in an outer protective bag. Between the inner and outer
bags there is an oxygen absorber and an oxygen indicator; the oxygen absorber sachet is made of inert
material and contains iron hydroxide.
Figure B: The upper chamber contains the glucose solution, the middle chamber contains the fat
emulsion, and the lower chamber contains the amino acid solution.
The glucose solution and amino acid solution are clear, colourless to straw-coloured.
The fat emulsion is milky white.
The upper and middle chambers can be connected to the lower chamber by opening internal seals.
Different pack sizes are supplied in cardboard boxes containing five bags.
Pack sizes: 5 x 1250 ml, 5 x 1875 ml and 5 x 2500 ml
Not all pack sizes may be marketed.
Marketing Authorisation Holder
B. Braun Melsungen AG
Carl-Braun-Straße 1
34212 Melsungen, Germany
Tel.: +49-5661-71-0
Fax: +49-5661-71-4567
Manufacturer
B. Braun Melsungen AG
Carl-Braun-Straße 1
34212 Melsungen, Germany
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder in Poland:
Aesculap Chifa sp. z o.o.
ul. Tysiąclecia 14
64-300 Nowy Tomyśl
Telephone: +48 61 442 01 00
Fax: +48 61 443 75 05
E-mail: [email protected]
This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland)
under the following names:
Austria Nutriflex Omega peri B.Braun Emulsion zur Infusion
Belgium Nutriflex Omega peri, 32 g/l Amino + 64 g/l G, emulsie voor infusie
Bulgaria Nutriflex Omega peri emulsion for infusion
Croatia Nutriflex Omega peri emulzija za infuziju
Cyprus Nutriflex Omega peri
Czech Republic Nutriflex Omega peri
Denmark Nutriflex Omega Peri
Estonia Nutriflex Omega peri infusiooniemulsioon
Finland Nutriflex Omega 32/64/40 perifer infuusioneste, emulsio
France PERINUTRIFLEX OMEGA E, émulsion pour perfusion
Germany NuTRIflex Omega peri novo Emulsion zur Infusion
Greece Nutriflex Omega peri
Ireland Omeflex peri emulsion for infusion
Italy Nutriplus Omega AA32/G64
Lithuania Nutriflex Omega peri infuzinė emulsija
Luxembourg NuTRIflex Omega peri novo Emulsion zur Infusion
Latvia Nutriflex Omega peri emulsija infūzijām
Netherlands Nutriflex Omega peri 32 g/l Amino + 64 g/l G, emulsie voor infusie
Norway Nutriflex Omega Peri infusjonsvæske, emulsjon
Poland Omegaflex peri
Portugal Nutriflex Omega peri emulsão para perfusão
Romania NuTRIflex Omega Peri novo emulsie perfuzabilă
Slovakia Nutriflex Omega peri
Slovenia Nutriflex Omega peri 32/64 emulzija za infundiranje
Spain Omegaflex peri emulsión para perfusión
Sweden Nutriflex 32/64/40 perifer infusionsvätska, emulsion
United Kingdom (Northern Ireland) Omeflex peri emulsion for infusion

Information intended exclusively for healthcare professionals:

Before using parenteral nutrition products, visually inspect for possible damage, discoloration, and emulsion instability.
Do not use bags that are damaged. The outer and inner bags, as well as the seals between compartments, must be intact. The product should be used only if amino acid and glucose solutions are clear and colorless to straw-colored, and the fat emulsion is homogeneous milky white in appearance. Do not use if the solutions contain particulate matter.
After mixing the contents of the three compartments, do not use if the emulsion shows discoloration or signs of phase separation (oil droplets, oil layer). In case of emulsion discoloration or phase separation, infusion must be immediately discontinued.
Before opening the outer bag, check the color of the oxygen indicator (see Figure A). Do not use if the oxygen indicator has changed to pink. Use only if the oxygen indicator is yellow.

Preparation of the mixed emulsion
Strict aseptic technique must be followed.
Opening: Tear the outer bag starting at the notches (Fig. 1). Remove the inner bag from the protective packaging. Discard the outer bag, oxygen indicator, and oxygen absorber.

Visually inspect the inner bag for possible leaks. Discard any leaking bag, as sterility cannot be guaranteed.

Mixing the bag contents and adding additional substances
To sequentially open the compartments and mix their contents, roll the bag with both hands, starting from the seal separating the upper compartment (glucose) and the lower compartment (amino acids) (Fig. 2).

Then continue pressing to open the seal between the middle compartment (lipids) and the lower compartment (Fig. 3).

After mixing the contents of all compartments and removing the aluminum foil (Fig. 3A), compatible additives may be added via the medication port (Fig. 4). Mix the contents thoroughly (Fig. 5) and visually inspect the mixture (Fig. 6). The mixture is a homogeneous milky white oil-in-water emulsion. Any signs of emulsion phase separation are unacceptable.

Omegaflex peri may be mixed with the following additives up to the maximum concentrations or total amounts specified below. The resulting mixtures have been shown to be stable for 7 days at +2°C to +8°C plus an additional 2 days at 25°C.

• Electrolytes: consider electrolytes already present in the bag; stability in the three-compartment mixture has been demonstrated up to a total of 200 mmol/L sodium + potassium (combined), 9.6 mmol/L magnesium, and 6.4 mmol/L calcium.
• Phosphate: stability has been demonstrated up to a maximum concentration of 20 mmol/L inorganic phosphate.
• Alanyl-glutamine: up to 24 g/L.
• Trace elements and vitamins: stability has been demonstrated when using commercially available multi-trace element and multivitamin products (e.g., Tracutil, Cernevit) at the standard dose recommended by the respective manufacturer.

Detailed information regarding the above additives and the corresponding shelf lives of such mixtures is available upon request from the manufacturer.

Preparation for infusion
Warm the emulsion to room temperature before infusion.
Remove the aluminum seal from the infusion port (Fig. 7) and connect the infusion set (Fig. 8). Use an infusion set without an air vent, or if using a set with an air vent, ensure the vent is occluded. Hang the bag on an infusion stand (Fig. 9) and administer by standard infusion technique.

For single use only. After use, dispose of the packaging and any unused remnants of the product.
Any unused medicinal product or waste material must be disposed of in accordance with local regulations.
Do not reconnect partially used containers.
If filters are required, they must be lipid-permeable (pore size ≥ 1.2 µm).

Shelf life after opening the outer bag and after mixing the bag contents
Chemical and physicochemical stability of the amino acid, glucose, and lipid mixture has been demonstrated for 7 days at 2–8°C and for an additional 2 days at 25°C prior to use.

Shelf life after addition of compatible additives
From a microbiological standpoint, the product should be used immediately after addition of additives. If not used immediately, the responsibility for storage duration and conditions prior to use lies with the user.

After first opening (puncturing the infusion port)
The emulsion should be used immediately after opening the container.

Omegaflex peri must not be mixed with other medicinal products for which compatibility has not been demonstrated.
Due to the risk of pseudoagglutination, Omegaflex peri should not be administered simultaneously with blood through the same infusion set.